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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SI-BONE, INC. IFUSE IMPLANT SYSTEM; ORTHOPEDIC ROD
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SI-BONE, INC. IFUSE IMPLANT SYSTEM; ORTHOPEDIC ROD Back to Search Results
Model Number 7065-90
Medical Device Problem Code Malposition of Device (2616)
Health Effect - Clinical Codes Undesired Nerve Stimulation (1980); Pain (1994)
Date of Event 08/10/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Based on the information provided, review of the surgical technique manual, ifu and fmea, there is no indication of device failure and no indication that the device was out of specification.The most probable root cause is improper implant size selection; using an implant that was too long.
 
Event or Problem Description
The patient had right side si joint arthrodesis around 2015 where three implants were placed.The patient presented to a new surgeon with complaints of radicular and lateral soft tissue pain caused by an implant that was too long.In (b)(6) 2017, the surgeon removed the implant.The remaining previous implants were not adjusted or removed.The status of the patient following the revision surgery is not known.
 
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Brand Name
IFUSE IMPLANT SYSTEM
Common Device Name
ORTHOPEDIC ROD
Manufacturer (Section D)
SI-BONE, INC.
3055 olin avenue
suite 2200
san jose CA 95128 2066
MDR Report Key6834109
Report Number3007700286-2017-00081
Device Sequence Number19111745
Product Code OUR
UDI-Device Identifier00859256003330
UDI-Public00859256003330
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K080398
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number7065-90
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/10/2017
Initial Report FDA Received Date08/31/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age50 YR
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